MAUDE Adverse Event Report: ARTHREX, INC. KNOTLESS TENSIONTIGHT BUTTON IMPLANT SYS; NON-DEGRADABLE FIXATN FASTENER

Model Number	KNOTLESS TENSIONTIGHT BUTTON IMPLANT SYS
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
On 10/17/2025, it was reported by a sales representative via (b)(4) that an ar-2350 knotless tensiontight button implant sys and an ar-3642sp knotless fibertak experienced a malfunction.When implanting the tension-tight button, flipping the button, and adding tension, the suture made a clean break at the button.This was discovered during the case with no patient harm.
Additional Manufacturer Narrative
Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The method of bone preparation and the quality of the bone encountered were not specified.The most likely cause of the reported failure can be attributed to user error of the device due to improper bone preparation; excessive force being used when inserting the button and/or the device coming in contact with another device during use.

• Brand Name: KNOTLESS TENSIONTIGHT BUTTON IMPLANT SYS
• Common Device Name: NON-DEGRADABLE FIXATN FASTENER
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 23413131
• Report Number: 1220246-2025-04866
• Device Sequence Number: 8945897
• Product Code: MBI
• UDI-Device Identifier: 00888867301924
• UDI-Public: (01)00888867301924(11)240603(17)290430(10)15256799
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K202444
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: KNOTLESS TENSIONTIGHT BUTTON IMPLANT SYS
• Device Catalogue Number: AR-2350
• Device Lot Number: 15256799
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2025
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/03/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown